Gastric cancer
Conditions
Interventions
Experimental group:Envafolimab+ XELOX /SOX
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. The enrolled patients must meet the criteria of locally advanced gastric cancer (LAGC), mainly referring to clinical stages of cT1-2N+M0 or cT3-4b any NM0. 3. The disease must have progressed after previous use of PD-1/PD-L1 treatment, excluding those who permanently discontinued the treatment due to grade 3 or higher immune-related toxic reactions in the past; 4. The enrolled patients should complete the detection of immune-related indicators such as PD-L1, TMB, and MSI as much as possible; 5. Within the past 6 months, there must not have been congestive heart failure, unstable angina pectoris, or unstable arrhythmia; 6. The patient's activity status score is rated from 0 to 3 using the Eastern Cooperative Oncology Group (ECOG) scoring method, with an expected life expectancy of >= 3 months; 7. There must be no severe hematopoietic function, heart, lung, liver, or kidney dysfunction and immune deficiency in the past; 8. One week before enrollment, neutrophils should be >= 1.0×10^9/L; AST and ALT should be <= 3.0 times the upper limit of normal (for patients with liver cancer or liver metastasis cancer, <= 5.0 times the upper limit of normal); creatinine should be <= 3.0 times the upper limit of normal; 9. The patient must have the ability to understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant women, women in the process of pregnancy or breastfeeding; 2. Those who have a history of other malignant diseases within the last 5 years, except for cured skin cancer and cervical carcinoma in situ; 3. Those with uncontrolled epilepsy, central nervous system diseases or mental disorders, as determined by the researchers, whose clinical severity may prevent them from signing the informed consent form or affect their compliance with drug treatment; 4. Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, NYHA class II or more severe congestive heart failure or severe arrhythmias requiring drug intervention, or a history of myocardial infarction within the last 12 months; 5. Those requiring immunosuppressive therapy due to organ transplantation; 6. Known major active infections, or as determined by the researchers, significant blood, kidney, metabolic, gastrointestinal, endocrine function or metabolic disorders, or other serious uncontrolled concomitant diseases; 7. Those allergic to any components of the study medication; 8. Those with a history of immunodeficiency diseases, including positive HIV testing or having other acquired or congenital immune deficiency diseases, or those with a history of organ transplantation, or those with other immune-related diseases requiring long-term oral hormone treatment; 9. Those in the acute or chronic stage of tuberculosis infection (patients with positive T-spot test and suspicious tuberculosis lesions on chest X-ray); 10. Other situations that the researchers consider unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactXiaosong Ge
Affiliated Hospital of Jiangnan University
Outcome results
None listed